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STAT+: Pharmalittle: We’re reading about FDA guidance on AI, meds releasing ‘forever chemicals,’ and more

STAT

As of last October, the agency had received more than 500 drug submissions with AI components going back to 2016, with a large number in the areas of oncology, neurology, and gastroenterology.   Most of the compounds came from commonly prescribed medications including antidepressants and statins.

FDA 103
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Understanding Large Molecule Drug Development: From Biologics to Market

Impact Pharmaceutical Services

Nonetheless, their rising popularity – eight of the top 10 best-selling drugs internationally in 2016 were biologics – underscores their increasing importance. This documentation supports process control, and optimization, and serves as a regulatory record of reliability and repeatability.

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Black Seed Oil and Hashimoto’s

The Thyroid Pharmacist

Black seed oil has likely been used as a medicinal herb for 3000 years or more, and its use has been documented in Ayurveda, Unani, Tibb, Siddha, and other systems of medicine. [4] Black seed oil also contains the antifungal compounds thymol and THQ. A 2016 study found that TQ was able to eradicate 96.8 2016; 16: 471.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. The intricate nature of botanical products further compounds the challenge, demanding a paradigm shift in regulatory interpretation and QC standards. 3 Is two too few? BMB Reports. 2017;50(3):111–6.

FDA 103
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Accommodating Multiple Modalities in the Same Facility

ISPE

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. Manufacturing of (or with) high-potent compounds in adjacent suites may be possible with the appropriate engineering controls and risk assessments based on toxicity data.

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CMC Requirements for New Drug Registration in Latin America

ISPE

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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Nine for 2023, part one: a reflection on inflection

pharmaphorum

For pharma, the impact in critical areas such as the performance of newly marketed innovation has already been documented. Research and development spend by major companies has increased 44% since 2016.